Friends of Cancer Research (Friends) is pleased to announce the publication of our new perspective on the significance of pragmatic clinical trials (PCTs) in ESMO Real World Data and Digital Oncology. PCTs evaluate the effectiveness of interventions in settings that more closely resemble real-world care, aiming to produce evidence directly applicable to clinical practice. Recognizing the value that PCTs bring to oncology drug development, Friends has been actively working with stakeholders to support integrating pragmatic elements into conventional clinical trials. Friends convened a working group to generate a white paper focused on PCTs at our 2023 Annual Meeting and continues to work with stakeholders to explore how pragmatic elements can be incorporated into clinical trials to enhance operational efficiencies and lead to better outcomes for patients.
While PCTs are not new, increased attention is being placed on how pragmatic elements can be integrated into conventional clinical trials to enhance equitability and ensure representativeness, thereby enhancing evidence generation and potentially supporting regulatory decision-making. In oncology drug development, incorporating a hybrid approach to trials could also help accelerate the availability of new therapies and ensure the adaptability of research findings into clinical practice while still meeting regulatory standards.
We will host a session focused on PCT design in the post–market setting at the Friends’ Annual Meeting 2024. We look forward to furthering these important discussions and advancing the field of oncology drug development.
Key Insights to Pragmatic Clinical Trial Elements and Why they Matter:
- Real-world Relevance: PCTs evaluate interventions in settings that mirror everyday clinical practice, enhancing generalizability of results to diverse patient populations.
- Broadened Eligibility: PCTs more accurately represent real-world patient demographics and accommodate those with comorbidities and varying performance statuses.
- Simplified Study Procedures: PCTs feature streamlined protocols and data collection methodologies, reducing participant burden and enhancing recruitment and retention.
- Support for Regulatory Decision-Making: PCTs can provide relevant and applicable data that could inform regulatory decisions regarding drug approvals and usage and help to efficiently fulfill certain regulatory obligations.
- Patient-Centric Outcomes: PCTs prioritize outcomes that matter most to patients, such as overall survival, quality of life, and patient experience, aligning research with patient and clinician priorities.
Thank you to our authors: Mark D. Stewart1, Amy E. McKee2, Roy S. Herbst3, Hillary S. Andrews1, Brittany A. McKelvey1, Ellen V. Sigal1, Jeff D. Allen1
1. Friends of Cancer Research, Washington
2. Parexel International, Washington
3. Yale Cancer Center, Yale School of Medicine, New Haven, USA
